Download The Case Against Sulfuryl Fluoride

Fluoride Exposure from Pesticides:
The Case Against
SULFURYL FLUORIDE
Michael Connett, FAN
2nd Citizens’ Conference on Fluoride
July 30, 2006
Which Foods Can be Fumigated
with Sulfuryl Fluoride?
Dried Eggs
900 ppm
Wheat (flour & germ)
130 ppm
Oat (flour & rolled)
75 ppm
Legumes (57 types)
70 ppm
Processed Foods (ALL)
70 ppm
Barley (bran, flour, pearled)
45 ppm
Corn (meal & flour)
30 - 35 ppm
Other Tolerances
Allowable levels of fluoride “in or on” food:
70 ppm: Herbs & Spices (135 types)
40 ppm: Wheat (bran & grain)
40 ppm: Millet (grain)
45 ppm: Rice (flour)
40 ppm: Coconut
40 ppm: Cattle (meat, dried)
31 ppm: Rice (bran)
25 ppm: Rice (wild grain & polished)
25 ppm: Oat (grain)
Other Tolerances (cont.)
Allowable levels of fluoride “in or on” food:
20 ppm: Cocoa bean
15 ppm: Peanuts
15 ppm: Coffee
15 ppm: Barley (grain)
10 ppm: Corn (grain)
10 ppm: Tree Nuts (14 types)
7 ppm: Raisin
5 ppm: Cheese
5 ppm: Powdered Milk
3 ppm: Dried Fruit
How Much Fluoride Will We Ingest
From Fumigated Foods?
The Daily Dose for adults
0.67 mg/day
EPA’s estimate for the average
exposure to fluoride from SF
2nd Largest Daily Source of
Fluoride (EPA 2006)
The Daily Dose for children
0.08 - 0.57 mg/day
EPA’s estimate for a child’s average
exposure to fluoride from SF
2nd Largest Daily Source of
Fluoride (EPA 2006)*
The Daily Dose for children
Age
Avg. Dose from SF
< 1 yr
0.08 mg/day
1-2 yrs
0.26 mg/day
3-5 yrs
0.48 mg/day
6-12 yrs
0.57 mg/day
EPA, Final Health Risk Assessment, January 2006
How Did this Happen?
EPA’s Risk Assessment
Food Quality Protection Act (FQPA)
“When setting new tolerances, or reassessing existing tolerances or tolerance
exemptions, EPA must now focus explicitly on exposures and risks to children and
infants. EPA must,
1) explicitly determine that the tolerance is safe for children;
2) consider the need for an additional safety factor of up to ten-fold to account
for uncertainty in the data base relative to children unless there is evidence that a
different factor should be used; and
3) consider children's special sensitivities and often unique exposure patterns
to pesticides.”
-- EPA, Federal Register, January 31, 1997
Did EPA:
“explicitly determine that the tolerance
is safe for children?”
FQPA Requirement
An Adult-Based
Health Standard (MCLG)
•For its risk assessment, EPA used the “MCLG” (Maximum
Contaminant Level Goal)
•Set by EPA’s Office of Water in 1985.
•Vigorously criticized by Natural Resources Defense Council
(NRDC) and EPA Headquarters Union.
A glimpse into the history…
“there was a consensus that mottling or pitting of teeth
could represent as yet unknown skeletal effects in
children and that severe dental fluorosis per se
constitutes an adverse health effect that should be
prevented.”
-Surgeon General’s Panel on the Non-Dental Effects of
Fluoride (1983)
Problems with MCLG
Assumption #1:
Severe Dental Fluorosis is not an adverse health effect
Problems with MCLG
Assumption #2:
Crippling Skeletal Fluorosis is the ONLY adverse effect
fluoride has on bone.
Problems with MCLG
Assumption #3:
20 mg/day is the lowest dose that could
harm human health.
Problems with MCLG
Assumption #4:
Fluoride has NO effect on ANY soft tissues
(at less than 50 ppm in water).
Basis of MCLG
•20 mg/day considered the “lowest observable
adverse effect level” for crippling fluorosis.
•A safety factor of 2.5 used, resulting in a safe dose
of 8 mg/day.
•Assuming people drink 2 liters of water a day &
assuming no other sources of fluoride, EPA set the
MCLG at 4 mg/L (8 mg/day / 2 liters = 4 mg/L).
Converting MCLG into a
“Reference Dose”
EPA Pesticide Division has traditionally derived its
“reference dose” from the MCLG as follows:
•“Safe” dose = 8 mg/day (2 liters of 4 ppm)
•The average adult weighs 70 kilograms (kg)
•8 mg divided by 70 kg = 0.114 mg/kg
Reference Dose =
0.114 mg/kg/day
(milligrams per kilogram of bodyweight per day)
Did EPA:
“consider the need for an additional safety factor
of up to ten-fold to account for uncertainty
in the data base relative to children”?
FQPA Requirement
Reasons why Additional Safety Factor
for Children would be Appropriate
•Exposure during childhood causes severe dental fluorosis.
•Children’s bones are probably more, not less, susceptible
to fluoride damage (Surgeon General 1983).
• New research (published after MCLG was adopted) has
raised additional health concerns from childhood exposure:
•Neurotoxicity (Xiang 2003)
•Osteosarcoma (Bassin 2006)
•Kidney damage (Xiong 2006)
•Endocrine effects (Lin Fa-Fu 1991)
So, what happened?
DOW Agrosciences (2002):
“These levels of dietary exposure in combination with the
potential dietary exposures that the proposed uses of
ProFume would represent are considerably lower than the
USEPA MCLG for fluoride of 0.114 mg/kg/bwt/day."
http://www.fluoridealert.org/pesticides/sulfuryl.f.fr.Feb.15.2002.htm
EPA (2002):
"In consideration of the proposed temporary tolerances for
walnuts and raisins, the Agency used the maximum
concentration limit goal (MCLG) of 4.0 ppm
(0.114 mg/kg/day).”
http://www.fluoridealert.org/pesticides/sulfuryl.f.fr.Feb.7.2002.htm
Ooops….
Fluoride Exposure (mg/kg)
Levy (2003)
Age (mo)
90th%
95th%
Max
1.5
0.159
0.188
0.401
6
0.127
0.147
0.343
12
0.086
0.103
0.272
24
0.098
0.128
0.298
32
0.098
0.115
0.223
RED = Exceeds EPA’s reference dose (0.114 mg/kg)
Making a bad standard, worse
After it became apparent that some children are
already exceeding 0.114 mg/kg, EPA increased the
allowable dosage for children.
Increasing the Safe Dosage
< 2003
January 2004
July 2005
Age
Initial Safe
Dosage
2nd Safe
Dosage
3rd Safe
Dosage
< 1 yr old
0.114 mg/kg
0.571 mg/kg
1.14 mg/kg
1-2 yrs old
0.114 mg/kg
0.308 mg/kg
0.615 mg/kg
3-5 yrs old
0.114 mg/kg
0.182 mg/kg
0.364 mg/kg
Making a bad standard, worse
The allowable dosage is now
10 times higher for infants than for adults
Problems with New “Safe Dosage”
•Not based on new data or research.
•Contradicts key component (SMCL) of EPA’s safe
drinking water standard for fluoride.
•Dwarfs the dose that causes severe dental fluorosis.
•Exceeds the dosage (0.45 mg/kg/day) which increases
bone fractures in less than 2 years in clinical trials with
adult osteoporosis patients.
Did EPA:
“consider children's… often
unique exposure patterns”?
FQPA Requirement
EPA’s “Conservative” Estimate of
Toothpaste Ingestion
"Despite the variability in the estimates of ingested
toothpaste, maximum exposures to fluoride observed
in those studies appear to converge to approximately
0.3 mg/day (assuming 2 brushings per day). The
exposure estimates range from 0.004 to 0.04 mg/kg/day
and should be considered conservative in nature..."
EPA, Health Risk Assessment, January 2004
Fluoride Ingestion from Toothpaste
Published Data (2 brushings, 1000 ppm F)
Age (yrs)
Avg Intake
Max Intake
Study
2
0.66 mg/day
n/a
Naccahe ‘87
2.5
0.54 mg/day 1.66 mg/day
Bentley ‘99
2-3
0.56 mg/day
n/a
Simard ‘84
2-4
0.6 mg/day
>1.46 mg/d
Barnhart ‘76
3-6
0.76 mg/day
2.3 mg/day
Hargreaves
‘75
3
0.36 mg/day
n/a
Naccahe ‘85
4
0.78 mg/day
n/a
Simard ‘84
4
0.26 mg/day
0.6 mg/day
Ericsson ‘74
5
0.44 mg/day
n/a
Simard ‘84
Red: Exceeds EPA’s “Conservative Estimate” (0.3
mg/day)
Other Problems with
EPA’s Risk Assessment
Other Problems with EPA’s
Risk Assessment
•Under-estimated fluoride exposure among adults by
failing to account for high-end water consumers.
•Did a superficial analysis of acute fluoride toxicity by
only considering the dose that kills, vs the dose that causes
symptoms (nausea, vomiting, etc)
•Violated procedural requirements in a manner that
restricted input and participation from concerned parties.
•And more: See FAN’s petition to EPA for further details
Implications of NRC Report
Implications of NRC Report
•The increases in allowable childhood dosages will need to
be rescinded.
•A lower MCLG will necessitate a lower reference dose across
the board (both children and adults).
•Since many Americans are already exceeding current
reference dose, many more will exceed the new, lower one.
Q&A
The Reference Dose
EPA (2002):
“EPA has determined that the dose to be used for risk
assessment for exposure to fluoride is 0.114 mg F/kg/day,
per the 1996 Cryolite RED. This value is used for all
population subgroups ..."
http://www.epa.gov/fedrgstr/EPA-PEST/2002/April/Day-24/p9655.htm